Eisai and Biogen's (Nasdaq: BIIB) Alzheimer's drug candidate, LEQEMBI (lecanemab-irmb), received unanimous support from FDA PCNS panel based on Phase 3 Clarity AD trial data. 

The committee acknowledged its clinical benefit, overall benefit-risk profile, and discussed usage in specific subgroups. The PDUFA action date for traditional approval is July 6, 2023. 

Alzheimer's is a progressive disease characterized by a gradual worsening of dementia symptoms over several years. Initially, memory loss is mild, but as the disease advances, individuals with late-stage Alzheimer's experience a loss of communication skills and responsiveness to their surroundings.

Eisai takes the lead in the global development and regulatory submissions of LEQEMBI, with both companies co-commercializing and co-promoting the product. Eisai holds the final decision-making authority in this partnership.

Nasdaq halted trading of $BIIB on Friday, ahead of the FDA Advisory Committee meeting.

Disc Medicine Opco Inc. (Nasdaq: IRON) received an upgrade from Outperform to Strong Buy, with its price target raised from $50 to $75 by Raymond James. 

The company presented promising preliminary findings from its ongoing Phase 2 BEACON trial, which assessed the efficacy of bitopertin, a glycine transporter 1 (GlyT1) inhibitor, in patients with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). 

The trial data showed consistent decreases in Protoporphyrin IX (PPIX) levels, significant improvements in reported sunlight tolerance, and enhancements in measures of patient quality of life. 

In response to the news, $IRON closed at $45.69, reflecting an increase of $6.22 (15.76%) on Friday.

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